DONEPEZIL HYDROCHLORIDE Recall D-0177-2024
Description: Donepezil HCl Tablets, 5 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto Rico 00791. NDC: 43547-275-09
DONEPEZIL HYDROCHLORIDE Recall D-0177-2024 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0177-2024 |
| Event ID | 89450 |
| Brand | DONEPEZIL HYDROCHLORIDE |
| Generic Name | DONEPEZIL HYDROCHLORIDE |
| Manufacturer | DONEPEZIL HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | DONEPEZIL HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | Nationwide USA |
| Quantity | 1 unit |
| Recall Reason | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
| Drug Classification | Class II |
| Drug Code Info | 20240103 |
| Product NDC | 43547-275 43547-276 |
| Drug UPC | 0343547276034 0343547275037 |
| Recall Initiation Date | 20220126 |
| Report Date | 20240103 |
| Classification Date | 20231226 |
| Address | 7200 Cardinal Pl W Dublin, OH 43017-1094 United States |
| Recalling Firm | CARDINAL HEALTHCARE |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 3O2T2PJ89D |
| Drug Application Number | ANDA200292 |
| Structured Product Labeling (SPL ID) | 2ae1a4fe-ec65-4546-a4a7-1377ab1872bd |
| Structured Product Labeling (SPL Set ID) | 042a59ea-131a-4806-b0f4-2f791d4414e2 |
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